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Cyltezo News

US FDA Approves High-Concentration, Citrate-Free Formulation of Cyltezo (adalimumab-adbm) injection

RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of ...

Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products

October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...

Treatment Effect of Tofacitinib, Adalimumab Compared in RA

WEDNESDAY, July 12, 2023 – For adults with rheumatoid arthritis (RA), there is a modest reduction in the mean Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) at three months...

US FDA Approves the Cyltezo Pen, a New Autoinjector Option, Ahead of July 1 Commercial Launch

RIDGEFIELD, Conn., May 22, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for ...

U.S. FDA Approves Cyltezo (adalimumab-adbm) as First Interchangeable Biosimilar to Humira

Regulatory approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s Phase III randomized VOLTAIRE-X clinical trial Data showed that switching several times b...

FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira

November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (a...

FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira

Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its...

FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira

Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a p...

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Ankylosing Spondylitis, Crohn's Disease, Crohn's Disease - Maintenance, Plaque Psoriasis, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis

Cyltezo patient information at Drugs.com